Biomedical Advanced Research and Development Authority
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.
BARDA manages the procurement and advanced development of medical countermeasures for chemical, biological, radiological, and nuclear agents, as well as the advanced development and procurement of medical countermeasures for pandemic influenza and other emerging infectious diseases.
Public Concerns with Lack of Transparency
Sen. Richard Burr (R-NC) has introduced the Biodefense and Pandemic Vaccine and Drug Development Act of 2005, S1873, that would create a new agency in the Department of Health and Human Services(HHS) to research and develop strategies to combat bio-terrorism and natural diseases. While Congress has created several agencies recently in response to homeland security concerns, most notably the Department of Homeland Security, Burr proposes for the first time ever to completely exempt this new agency from all open government laws.
Neither the CIA nor the Defense Department has such an exemption.
The Freedom of Information Act, however, already includes an exemption for national security information, as well as eight other exemptions ranging from privacy issues to confidential business information and law enforcement investigations. If the public disclosure of information would threaten national security, then the government may withhold the requested information.
"The well-established and time-tested FOIA (Freedom of Information Act) provisions already address Burr's concerns," explains Sean Moulton, OMB Watch senior policy analyst, "thereby making the blanket exemption for BARDA unnecessary and unwise."
Congress established and strengthened FOIA over the years to create a reasonable, consistent level of accountability among government agencies. Under FOIA, when the public requests agency records, the agency is compelled to collect and review the requested information. The only decision for the agency is whether specific records can or can not be released under the law based on the exemptions from disclosure written into the law. However, the Burr legislation reverses the process: it does not require BARDA to collect or review the requests for disclosure.
Instead, the agency can automatically reject requests. Still more troubling, the law prohibits any challenges of determinations by the Director of BARDA or Secretary of HHS, stating that the determination of the Director or Secretary with regards to the decision to withhold information "shall not be subject to judicial review."
Mark Tapscott at the Heritage Foundation writes that "BARDA will essentially be accountable to nobody and can operate without having to worry about troublesome interference from courts or private citizens like you and me."
Additionally:
The Homeland Security Act of 2002 gives the Secretary of Health and Human Services (HHS) the right to authorize mandatory vaccinations and drugging once a state of emergency is implemented.
This new act will exempt pharmaceutical companies from any liability for death or injury as long as their drug or vaccine has been designated as a “countermeasure.”
http://www.fromthewilderness.com/free/ww3/100205_health_tyranny.shtml - by Michael Kane
http://www.foreffectivegov.org/node/2702
http://usgovinfo.about.com/od/rightsandfreedoms/a/bardabill.htm
(From Wikipedia page on "Biodefense and Pandemic Vaccine and Drug Development Act of 2005")
The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (S. 1873), nicknamed "Bioshield Two" and sponsored by Senator Richard Burr (R-North Carolina), aims shorten the pharmaceutical development process for new vaccines and drugs in case of a pandemic, and to protect vaccine makers and the pharmaceutical industry from legal liability for vaccine injuries.
Support
Much of the support for the bill comes from Pharmaceutical Research and Manufacturers of America (PhRMA) and its members. In the 2002 election cycle, PhRMA contributed $3,505,052 to politicians, with 95% going to Republicans. The top recipient in the Senate was the bill's sponsor, Senator Richard Burr, who received $288,684, according to the non-partisan Center for Responsive Politics.
Senator Burr said the legislation "creates a true partnership" between the federal government, the pharmaceutical industry and academia to "walk the drug companies through the Valley of Death" in bringing a new vaccine or drug to market.
Exemptions from open records and meetings laws would streamline the development process, safeguard national security and protect the proprietary interests of drug companies, say Republican backers of the bill.[2] Opposition
Senator Chris Dodd (D-Connecticut) said "Their plan will protect companies that make ineffective or harmful medicines, and because it does not include compensation for those injured by a vaccine or drug, it will discourage first responders and patients from taking medicines to counter a biological attack or disease outbreak."[3]
Requirements Setting
Medical countermeasure requirements in BARDA provide a solid foundation for establishing advanced development and acquisition programs that support the overarching ASPR mission of reducing the adverse health effects of public health emergencies, including those caused by pandemic influenza, CBRN threat agents and emerging diseases. These requirements are critical to establishing programs to meet our preparedness goals. They also create incentives for industry participation and shape the market for countermeasure products.
Requirements for medical countermeasures for CBRN threats are defined with input from stakeholders across the federal government within the structure of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). Once established, these requirements drive BARDA advanced development and acquisition programs, as well as research, development, and acquisition efforts in HHS. CBRN medical countermeasure requirements are consistent with the planning and prioritization expressed in the HHS PHEMCE Implementation Plan for CBRN Threats.[1]
Pandemic Influenza requirements are defined by strategic objectives established in the National Strategy for Pandemic Influenza[2] and the HHS Pandemic Influenza Plan.[3]
Advanced Research and Development
From its inception, BARDA has been committed to creating a robust and dynamic pipeline of medical countermeasures through advanced development of new and improved medical countermeasures. The goal of medical countermeasure development is to provide multiple product candidates in each program to both account for attrition in medical countermeasure development and to establish multi-product/multi-manufacturer portfolios for sustainability and redundancy.
BARDA medical countermeasures include vaccines, antimicrobial drugs, therapeutic products, diagnostics and non-pharmaceutical medical supplies and devices for public health medical emergencies including chemical, biological, radiological, and nuclear threats, pandemic influenza and emerging infectious diseases. BARDA currently has three programs dedicated to overseeing the advanced development of these medical countermeasures: Chemical, Biological, Radiological, and Nuclear (CBRN); pandemic influenza; and emerging infectious diseases. BARDA’s Influenza and Emerging Diseases Division is in the planning phase for its Emerging Infectious disease program. This program will, when stood up, support the advanced development of vaccine, therapeutic and diagnostic medical countermeasures that address emerging disease threats.
Integrated National Biodefense Medical Countermeasures Portfolio
Integrated National Biodefense Medical Countermeasure Portfolio “One-Portfolio Approach.” The Department of Defense (DoD) and HHS each identify medical countermeasure requirements to address their different missions and focus. DoD’s focus is on protecting the armed forces prior to exposure, whereas HHS’s focus is on response to threats to the civilian population after exposure in a CBRN event. However, there are areas of common requirements or interest where medical countermeasure candidates, resources and information can be appropriately shared to maximize opportunities for success in the development of medical countermeasures for the highest priority threats. BARDA, in partnership with other HHS and DoD partners, is leading an Integrated National Biodefense Medical Countermeasure Portfolio to leverage resources and programs across the agencies that develop and acquire CBRN medical countermeasures to more effectively address the broad range of common threats and requirements. Members of this Integrated Portfolio include BARDA, biodefense programs in NIAID and other Institutes of NIH, and multiple elements of the DoD Chemical and Biological Defense Program
Stockpiling Programs
The Pandemic and All Hazards Preparedness Act (PAHPA) established BARDA as the focal point within HHS for the advanced development and acquisition of medical countermeasures to protect the American civilian population against Chemical, Biological, Radiological, and Nuclear (CBRN) and naturally occurring threats to public health.
BARDA’s stockpiling efforts are focused on building reserves of critical countermeasures as they emerge from Advanced Development. Stockpiling contributes to preparedness in two ways:
- Stockpiled medical countermeasures directly support readiness, as the stockpiled products can help to mitigate the effects of an event or outbreak.
- Establishment of the stockpile helps to ready suppliers to meet the increased demands that an event will bring about, becoming practiced in the production and delivery of products.
BARDA’s acquisitions for the stockpile are not one-time events, complete upon the approval/licensure of a product. Rather, programs are structured to include incremental milestone acquisitions during late stage development, to make available products still in development that may increase preparedness in an event, pending Emergency Use Authorization. Furthermore, we aim to establish stockpiling milestones to address long term commitments post-licensure.
CBRN Stockpiling Programs
In FY 2004, Congress appropriated $5.6 billion to the Project BioShield Special Reserve Fund (SRF) to support the Project BioShield goal of acquiring CBRN medical countermeasures over a 10-year period. BARDA has used these funds to support major acquisition programs leading to procurement of medical countermeasures against top priority threats.
Pandemic Influenza Stockpiling Programs
Using funds from the Pandemic Influenza Emergency Supplemental Fund, BARDA is leading the nation toward the vaccine and antiviral stockpile goals for preparedness for pandemic influenza.
Manufacturing and Infrastructure Building
Ensuring the availability of medical countermeasures for public health emergencies is central to BARDA’s mission. This includes ensuring that manufacturing infrastructure is sufficient to support the production of required products, in a manner that is timely, reliable and cost effective.
BARDA is taking several approaches to bringing online the necessary infrastructure for medical countermeasure manufacturing. We are supporting the construction of new facilities as well as retrofitting existing facilities for maximal capacity and flexibility. We are also exploring the use of multiproduct manufacturing facilities to provide flexibility and surge capacity. So that we are able to rapidly provide countermeasures in the dosage forms required for use in the field, we are establishing a network of formulation/fill-finish manufacturers for emergency production and distribution. BARDA is also exploring the creation of centers of excellence for the development and production of non-commercial products, with assistance from industry partners.
Advancing Innovation
The Pandemic and All Hazards Preparedness Act (PAHPA) charges BARDA to support innovation to reduce the time and cost of medical countermeasures and product advanced research and development. This is to be accomplished through development of technologies that assist the advanced development of countermeasures, investment in research tools and technologies, and research to promote strategic initiatives including rapid diagnostics, broad spectrum antimicrobials, and vaccine manufacturing technologies.
We see this innovation mandate as an opportunity to work with our partners (including NIH, DoD, CDC, industry, and academia) to create new ways to “make medical countermeasure better.” Examples of this approach to innovation could include the development of animal models to support efficacy testing, immune modulation and other broad-spectrum approaches, immunity assessment, and analytical (potency) assays.
An example of innovation from the Pandemic Influenza program is BARDA’s Mix and Match study, assessing various combinations of antigens and adjuvants to obtain a more robust immune response. BARDA plans to support similar initiatives, leveraging technology platforms and products from multiple companies. PAHPA provided an important “antitrust” authority that is used to facilitate cooperation among companies for whom such cooperation would otherwise be difficult to accomplish.
BARDA’s Strategic Science Team helps bring innovation to our programs. This team is the focal point for discussions with the creators of new technologies, ideas, and products. Together with the program managers, they seek ways to integrate innovative science into the development and production of medical countermeasures.
See also
- Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (H.R. 307; 113th Congress) - one law regarding BARDA
References
- ↑ HHS PHEMCE Strategy and Implementation Plan
- ↑ National Strategy for Pandemic Influenza
- ↑ HHS Pandemic Influenza Plan